Funding for the IBD/FBD Review Group (September 1, 2010 - August 31, 2015) has been provided by the Canadian Institutes of Health Research (CIHR) Knowledge Translation Branch (CON - 105529) and the CIHR Institutes of Nutrition, Metabolism and Diabetes (INMD); and Infection and Immunity (III) and the Ontario Ministry of Health and Long Term Care (HLTC3968FL- 2010-2235). Ms. Ila Stewart has provided support for the IBD/FBD Review Group through the Olive Stewart Fund.
Sargramostim (GM-CSF) for induction of remission in crohn's disease: A cochrane inflammatory bowel disease and functional bowel disorders systematic review of randomized trials†
Article first published online: 2 MAY 2012
Copyright © 2012 Crohn's & Colitis Foundation of America, Inc.
Inflammatory Bowel Diseases
Volume 18, Issue 7, pages 1333–1339, July 2012
How to Cite
Roth, L., MacDonald, J. K., McDonald, J. W.D. and Chande, N. (2012), Sargramostim (GM-CSF) for induction of remission in crohn's disease: A cochrane inflammatory bowel disease and functional bowel disorders systematic review of randomized trials. Inflamm Bowel Dis, 18: 1333–1339. doi: 10.1002/ibd.22973
- Issue published online: 11 JUN 2012
- Article first published online: 2 MAY 2012
- Manuscript Accepted: 14 MAR 2012
- Manuscript Received: 5 MAR 2012
- Crohn's disease;
We planned to systematically review the efficacy of sargramostim (granulocyte colony stimulating factor [GM-CSF]) for remission induction in patients with Crohn's disease (CD).
A literature search to April 2011 was performed to identify all randomized trials studying sargramostim in patients with CD. The Cochrane risk of bias tool was used to evaluate study quality and the GRADE criteria were utilized to assess the overall quality of the evidence.
Three randomized studies (total 537 patients) were identified. The risk of bias was low for the three included studies. There was no statistically significant difference in the proportion of patients who achieved clinical remission (GM-CSF 25.3%; placebo 17.5%; relative risk [RR] 1.67; 95% confidence interval [CI] 0.80–3.50; P = 0.17), or 100-point clinical response (GM-CSF 38.3%; placebo 24.8%; RR 1.71 95% CI 0.98–2.97; P = 0.06). There was no statistically significant difference in the proportion of patients (GM-CSF 95.8%; placebo 89.3%) who experienced adverse events (RR 1.07; 95% CI 0.99–1.16; P = 0.08), or serious adverse events (GM-CSF 12.0% vs. placebo 4.8%; RR 2.21; 95% CI 0.84–5.81; P = 0.11).
Sargramostim does not appear to be more effective than placebo for induction of clinical remission or improvement in active CD. However, the GRADE analysis indicates that the overall quality of the evidence for the primary and secondary outcomes was low due to sparse data and heterogeneity, indicating that further research likely would have a significant impact on the effect estimates. (Inflamm Bowel Dis 2012;)